The gazette notification detailing the pharmaceutical pricing mechanism is scheduled to be presented to Parliament on Tuesday (21).
The presentation to Parliament, confirmed by National Medicines Regulatory Authority (NMRA) Chairman Dr. Ananda Wijewickrama, is the final step required by the NMRA Act to formalise the mechanism, which has already led to significant price reductions for several medicines.
The NMRA, which was established in March 2015 and made operational by July 2015 under the NMRA Act, is legally mandated to control the pricing of pharmaceuticals. Dr. Wijewickrama noted that the authority first began setting maximum ceiling prices in 2016.
However, its regulatory efforts have been consistently challenged.
The NMRA Chairman revealed that pharmaceutical importers had initially filed a court case as far back as 2017. The situation intensified when importers filed a subsequent case and obtained an injunction in December 2023, halting price control measures on the grounds that a proper pricing mechanism had not been formally published.
To overcome the legal barrier and remove the injunction, the Ministry of Health appointed a committee to consult with stakeholders and finalise a new regulatory framework. This process culminated in the publication of the final pricing mechanism gazette in July this year (Extraordinary Gazette No. 2446/34).
“After the gazette was published, the injunction was removed,” Dr. Wijewickrama stated, confirming the regulatory body was now fully empowered to proceed.
With the NMRA’s mandate restored, the authority has accelerated its work to enforce cost control measures. “We are now giving prices to individual medicines at the time of registration or re-registration,” Dr. Wijewickrama said.
According to him, this process has already enabled the NMRA to implement price fixes that have “significantly” reduced the cost of several essential medicines, promising relief to patients across the country once the gazette receives parliamentary approval this week.
Meanwhile, All-Island Private Pharmacy Owners’ Association (AIPPOA) President Chandika Gankanda said that the association had filed a writ application challenging the recently gazetted pharmaceutical pricing mechanism, noting that it failed to consider the profit margins of all stakeholders.
“Our margins have not been clarified properly; only the final prices are specified. The importer, distributor, and retailer all need to be reflected in the pricing mechanism,” he said, adding that the next court hearing was scheduled for 30 October.
Gankanda explained that this was the fourth case filed against the pricing formula, which he said had repeatedly been published and withdrawn. He emphasised that while the industry supported regulation, it had to be fair and practical, accounting for operational costs such as temperature-controlled storage and round-the-clock air conditioning.